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Can a pill combo outperform standard therapy for a Hard-to-Treat lung cancer?

NCT ID NCT06416410

Disease control Sponsor: Allist Pharmaceuticals, Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Aug 13, 2026 · Last updated Aug 14, 2026 · Updated 1 time

Summary

This phase 3 trial is investigating whether a combination of two oral drugs, JAB-21822 and JAB-3312, can work better than the current standard treatment (immunotherapy plus chemotherapy) as a first-line therapy for people with advanced non-squamous non-small cell lung cancer that has a specific KRAS G12C mutation. The study will compare how long participants live without their cancer progressing, as well as overall survival and tumor response. The trial aims to enroll about 392 adults who have not yet received systemic treatment for their advanced disease.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
A combination of two experimental drugs, JAB-21822 and JAB-3312, taken as oral tablets, compared to a standard immunotherapy plus chemotherapy regimen.
What this could lead to
If successful, this combination could offer a new first-line treatment option for people with advanced KRAS G12C-mutated non-small cell lung cancer, potentially improving how long they live without the disease progressing.
What could go wrong
This is an early-stage comparison in a specific patient group, and the experimental combo may not prove more effective than the standard treatment. Side effects from the drug combination are also possible.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 392 people

The number the study aims to enrol. It can still change while the study runs.

Started

Aug 2024

Expected to finish

Aug 2030

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * A signed written informed consent is required before performing any study-related operations * Age greater than or equal to 18 years old * Histologically or cytologically confirmed locally advanced/metastatic, unresectable non-squamous NSCLC with KRAS p. G12C mutation confirmed by the central lab * No history of systemic anticancer therapy to the local advanced/metastatic disease * Expected survival period greater than or equal to 3 months * Having at least one target lesion according to RECIST 1.1 * Eastern Cooperative Oncology Group (ECOG) ≤ 1 Exclusion Criteria: * Previous (≤2 years) or current solid tumors or hematologic tumors of other pathological types * Carry other driver gene mutations with available target therapy, or carry other KRAS mutations * Subjects with untreated central nervous system (CNS) metastases were excluded; * Uncontrolled pleural effusion, pericardial effusion, and ascites * Subjects with impaired heart function or clinically significant heart disease

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Conditions

The condition(s) this trial relates to.

non-small cell lung carcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Advanced non-squamous non-small-cell lung cancer Metastatic non-squamous non-small cell lung cancer

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    37 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Anhui Province cancer hospital

    NOT_YET_RECRUITING

    Hefei, Anhui, 230031, China

  • Beijing Cancer Hospital

    RECRUITING

    Beijing, Beijing Municipality, 100142, China

  • Beijing Chest Hospital ,Capital Medical University

    RECRUITING

    Beijing, Beijing Municipality, 101125, China

  • Beijing Tiantan Hospital, Captal Medical University

    NOT_YET_RECRUITING

    Beijing, Beijing Municipality, 100070, China

  • Cancer Hospital Chinese Academy Of Medical Sciences

    RECRUITING

    Beijing, Beijing Municipality, 100021, China

  • Cancer Hospital Chinese Academy Of medical Sciences Shenzhen Center

    NOT_YET_RECRUITING

    Shenzhen, Guangdong, 518116, China

  • Cangzhou hospital of integrated TCM-WM Hebei

    RECRUITING

    Cangzhou, Hebei, 061000, China

  • Fudan University Shanghai Cancer Center

    NOT_YET_RECRUITING

    Shanghai, Shanghai Municipality, 200032, China

  • Fujian cancer Hospital

    NOT_YET_RECRUITING

    Fuzhou, Fujian, 350014, China

  • Guangxi Medical University Cancer hospital & Guangxi Cancer Institute

    NOT_YET_RECRUITING

    Nanning, Guangxi, 530000, China

  • Harbin Medical University Cancer Hospital-Mammary gland of internal

    NOT_YET_RECRUITING

    Haerbin, Heilongjiang, 150081, China

  • Henan Cancer Hospital

    NOT_YET_RECRUITING

    Zhengzhou, Henan, 450003, China

  • Hubei cancer hospital

    NOT_YET_RECRUITING

    Wuhan, Hubei, 430079, China

  • Hunan Cancer Hospital

    NOT_YET_RECRUITING

    Changsha, Hunan, 410031, China

  • Jiangsu province hospital

    NOT_YET_RECRUITING

    Nanjing, Jiangsu, 210029, China

  • Jilin cancer hospital

    NOT_YET_RECRUITING

    Jilin City, Jilin, 130021, China

  • Liaoning Cancer Hospital & Institute

    NOT_YET_RECRUITING

    Shenyang, Liaoning, 110801, China

  • LinYi Cancer Hospital

    NOT_YET_RECRUITING

    Linyi, Shandong, 276002, China

  • Pecking Union Medical College Hospital

    NOT_YET_RECRUITING

    Beijing, Beijing Municipality, 100005, China

  • Peking University Third Hospital

    RECRUITING

    Beijing, Beijing Municipality, 100191, China

  • Shandong Cancer Hospital

    RECRUITING

    Jinan, Shandong, 250012, China

  • Shanghai Pulmonary Hospital

    NOT_YET_RECRUITING

    Shanghai, Shanghai Municipality, 200433, China

  • Shanxi province cancer hospital

    NOT_YET_RECRUITING

    Taiyuan, Shanxi, 030013, China

  • Sichuan province cancer hospital

    NOT_YET_RECRUITING

    Chengdu, Sichuan, 610041, China

  • Taizhou Hospital Zhejiang Province

    NOT_YET_RECRUITING

    Taizhou, Zhejiang, 317000, China

  • The First Affiliated Hosipital Of Zhengzhou University

    NOT_YET_RECRUITING

    Zhengzhou, Henan, 450052, China

  • The First Affiliated Hospital of Xi'An Jiaotong University

    NOT_YET_RECRUITING

    Xi’an, Shanxi, 710061, China

  • The First Hospital Of China Medical University

    NOT_YET_RECRUITING

    Shenyang, Liaoning, 110001, China

  • The First affiliated hospital Zhejiang university school of medicine

    NOT_YET_RECRUITING

    Hangzhou, Zhejiang, 310003, China

  • The Second Affiliated Hospital Zhejiang School of Medicine

    NOT_YET_RECRUITING

    Hangzhou, Zhejiang, 310003, China

  • The affiliated hospital of Qingdao university

    NOT_YET_RECRUITING

    Qingdao, Shandong, 266003, China

  • The first Affiliated Hospital, Sun Yat-sen University

    NOT_YET_RECRUITING

    Guangzhou, Guangdong, 510080, China

  • Tianjin Medical University Cancer Institute Hospital

    NOT_YET_RECRUITING

    Tianjin, Tianjin Municipality, 300181, China

  • Tongji Hospital Tongji Medical College of Hust

    NOT_YET_RECRUITING

    Wuhan, Hubei, 430030, China

  • Union Hospital Tongji Medical College Huazhong University of Science and Technology

    NOT_YET_RECRUITING

    Wuhan, Hubei, 430022, China

  • West China Hospital Sichuan University

    NOT_YET_RECRUITING

    Chengdu, Sichuan, 610044, China

  • Wuxi People's Hospital

    NOT_YET_RECRUITING

    Wuxi, Jiangsu, 214023, China

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